inforMED
MalfunctionFOX

STATLOCK PICC PLUS CRESCENT SLIDING POST

Received May 14, 2021 · Event occurred Mar 11, 2021

Report 3006260740-2021-01860 · MDR key 11825048

Device

Generic name

Stand, Infusion

Catalog number

PIC0220

Lot number

JUEW3275

Product problems

  • Misconnection
  • Misconnection

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEW3275 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED CLIPS THAT SECURE CATHETER IN PLACE ARE COMING UNCLIPPED. ADDITIONAL INFORMATION RECEIVED 04/26/2021: IT WAS REPORTED THERE WAS NO PATIENT HARM. THE MOVEABLE POSTS WERE INSERTED IN THE WINGS AND THE STATLOCK WAS APPLIED TO THE CHEST AREA, BELOW THE EXIT SITE OF THE CATHETER. THIS STATLOCK HAS BEEN USED FOR YEARS IN THIS WAY AND NEVER HAVE THE GATES POPPED OPEN AS THEY DO NOW. NURSES HAVE TAKEN TO TAPING OVED THE GATES TO KEEP IT SECURE.